Bengaluru: Hyderabad-based Bharat Biotech claims to make a “breakthrough” in developing two “candidate vaccines” against the deadly Zika virus, which has already aroused a global emergency, alarming many virologists.

The vaccines are said to be a “made in India” product.

Krishna Ella, managing director of Hyderabad-based Bharat Biotech, announced last week that his company is probably the first in the world to file a “global patent” for its vaccines against the virus that is suspected to cause birth defects and neurological problems and is terrorizing Brazil and other countries in South America. The company said it started work on the vaccines a year ago using “live” Zika virus. But, despite repeated requests from reporters, neither Ella nor the company’s spokesperson revealed from where or when the company got this virus.

“It is a serious question,” said Kalyan Banerjee, a renowned virologist and former director of the National Institute of Virology in Pune, a premier laboratory under the Indian Council of Medical Research (ICMR).

“Normally one should not import any exotic virus into the country under any pretext,” Banerjee told reporters in an email. “Only the government of India’s biotechnology board or a similar body is authorized to give permission to import after ascertaining all aspects of the virus.”

“It is amazing how the said laboratory obtained the live virus, particularly when there is no record of isolation of Zika virus from the Indian subcontinent,” Banerjee said.

The Zika virus is spread by the Aedes Aegypti species of mosquitoes that are abundant in India.

“Regarding the company getting the virus and making a vaccine, it needs to be carefully investigated,” Banerjee said, pointing out that “loopholes in the import of pathogenic agents may lead to national disaster”.

He said strict vigilance was one of the main reasons why the yellow fever virus – which is also spread by Aedes mosquitoes and causes a fatal disease – never came to India.

Durga Rao, another leading virologist at the Indian Institute of Science here, agrees.

One can import a virus from any source with approval from ICMR or the department of biotechnology, “but an unauthorized introduction of a virus which is not reported yet in India by anyone could be a serious regulatory problem as it can get into the environment easily under our unsupervised facilities”, Rao said in an email.

But inquiries reveal that the vaccine maker failed to follow the standard procedure for importing the live Zika virus whose potential threat to newborns forced the World Health Organization on February 1 to declare a global emergency.

“We did not import the virus and Bharat (Biotech) got it themselves,” ICMR director general Soumya Swaminathan told reporters in an email to a query if the company sought its permission to import.

“There are safety concerns with Zika virus vaccine — so all steps in regulatory approval need to be followed,” she said.

Asked if the DBT gave the permission, its secretary K Vijayraghavan – instead of an emphatic yes or no – said that the question “is best addressed to the industry concerned”. In an email, he said the DBT is committed to working with ICMR and the health Ministry to ensure preparedness.

Apart from its reluctance to reveal the source of the virus used to develop the vaccines, the company has declined to give details about the global patent it claims to have filed in July 2015.

A search of the Indian Patent Office website for Bharat Biotech’s patent applications, or the company’s own website, does not show any specific filing for the Zika virus. One patent expert told reporters that “it is possible that the patent office hasn’t yet published this patent application”.

Some scientists are impressed – and at the same time intrigued – by the Indian company’s foresight in trying to develop a vaccine for a disease that was not yet there.

According to a report in the journal Science, “less than a year ago, Zika seemed too trivial for anyone to bother developing countermeasures”, and Brazil reported its first case (microcephaly) of Zika virus only in May 2015.

“But Bharat Biotech says it started work on the vaccine as early as in 2014 and filed for patents for two vaccines in July 2015 itself,” said one medical researcher who did not want to be named. “This defies credibility.”

But Bharat Biotech has dismissed this argument saying the company was already developing vaccines for chikungunya and dengue and it was natural to work also on a vaccine for Zika virus which too is spread by the same species of mosquito.

Although the Indian company has an early start in vaccine development, bringing the vaccine to the market will be years away, experts say. There is no monkey model yet to enable comparisons of candidate vaccines and human trials have to be done in endemic countries like Brazil, not in India. (IANS)

Scientists have discovered that Zika virus infection that can lead to birth defects and other complications such as seizures and long-term deficits in brain structure and behaviour, also persists in adulthood.

In the study, a team of neuroscientists from the Federal University of Rio de Janeiro in Brazil, infected three-day-old infant mice with the Zika virus and monitored their behavioural and neurological development until adulthood to observe several early and late symptoms.

They found that most of the infected mice developed spontaneous seizures as soon as nine days after birth, and remained more susceptible to chemically-induced seizures in adulthood compared to controls.

This indicates that even though the spontaneous seizures may have been resolved as the animals grew older, the damage caused to the brain is permanent, the researchers said, in a paper published in the journal Science Translational Medicine.

Furthermore, the infected mice demonstrated weight loss that is not recovered in adulthood, cognitive deficits and long-lasting impaired motor function.

Representational image. Pixabay

The memory and sociability of adult mice were also affected, which may be linked to research that viral exposure shortly before or after birth may be associated to late development of autism and schizophrenia.

These behavioural deficits were also accompanied by persistent viral replication and inflammation in the brain.

The peak of viral replication in the brain was found to be associated with an abundance of molecules that mediate inflammation.

One of these molecules is the Tumor Necrosis Factor Alfa, or simply TNF-a, a molecule closely linked to episodes of acute inflammation in the body.

When administered, infliximab — a drug that inhibits TNF-a — prevented seizures in young infected mice by Day 12, suggesting that targeting cerebral inflammation could ameliorate some of the long-term consequences of neonatal Zika infection, the researchers said.

“Young mice responded very well to the TNF-a inhibitor. We found that some animals had a 50 per cent reduction in the number of seizures, on average. Also, adult animals were no longer susceptible to drug-induced seizures,” said Julia Clarke from the varsity. (IANS)